PDUFA funds creating "Catch-22"

Prescription drug user fees have dramatically reduced drug review times, but they have also had unintended negative impacts on FDA, Linda Suydam, the agency's senior associate commissioner said Wednesday. Speaking to the Food and Drug Law Institute, Suydam said the Prescription Drug User Fee Act (PDUFA) has created a "public health Catch-22," providing FDA funds to speed more drugs to the market, but failing to provide resources to cope with the additional drugs. She noted that new drugs create additional, and unfunded, obligations for FDA to monitor drug promotion and adverse events, as well as requirements for the agency to develop scientific expertise. She also said that government salary caps make it difficult to retain review staff; 40 FDA reviewers took private sector jobs last year, Suydam said. John Ford, counsel to the House Energy and Commerce Committee's Democratic members, said that Congress will consider expanding the scope of user fees to include post-market enforcement actions as part of negotiations for reauthorizing PDUFA. The act is set to expire in 2002. ...